Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care

NCT04031235 | Completed

• 1 other identifier: 2018-5564
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.

Conditions

Sudden Unexplained Infant Death; Child Rearing; Literacy

Outcome Measures

Primary Outcomes (3)

• Safe Sleep Knowledge

  The safe sleep assessment is based on a version developed by the PI and used in a recent published study, reflecting current AAP guidelines. Three questions are adapted from a published survey, gauging the mother's familiarity with SUID/SIDS (and briefly explaining if unfamiliar), whether she personally knows anyone who has lost a child to SUID/SIDS, and level of worry about SUID/SIDS for her baby. Our primary knowledge question utilizes an open-ended format, as no established tool for measuring SIDS knowledge was available: "Name as many things as you can think of to help keep your baby safe from SUID/SIDS (dying while asleep)." Maternal responses will be compared to an 11-item checklist of AAP safe sleep recommendations which are each referenced at least once in the book and brochures used, with 1 point awarded for each correct response.

  Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).

• Maternal impression of educational materials

  Mothers will be administered a brief survey (Likert scale) regarding how useful the respective book or brochure were to help them understand safe sleep practices and the importance of infant reading. They will also be asked if they still have the materials and how often they have reviewed them at home.

  Postpartum (<= 6 weeks)

• Clinical provider impression of educational materials

  Obstetric attending and resident physicians will be administered a brief survey (Likert scale) after the prenatal visit regarding how useful the respective book or brochure was to catalyze discussion of safe sleep and infant reading with the mother, with emphasis on feasibility in clinical practice.

  Prenatal/baseline visit (>=32 weeks gestation)

Secondary Outcomes (2)

• Home Literacy Orientation

  Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).

• DialogPR-I/T

  Postpartum (<= 6 weeks).

Study Arms (2)

Safe Sleep Education

EXPERIMENTAL

Mothers in the intervention group will receive education on American Academy of Pediatrics safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug). In addition, they will receive information on the importance of reading with their infant using a brochure created by the AAP.

Behavioral: Sleep Baby, Safe and Snug

Infant Reading Education

ACTIVE COMPARATOR

Mothers in the control group will receive education on American Academy of Pediatrics recommendations on reading and talking to infants using a specially-designed children's book (Read Baby, Every Day). In addition, they will receive information on safe sleep using a brochure created by the AAP.

Behavioral: Read Baby, Every Day

Interventions

Sleep Baby, Safe and Snug BEHAVIORAL

Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommended safe sleep practices. AAP safe sleep recommendations listed on the back cover.

Safe Sleep Education

Read Baby, Every Day BEHAVIORAL

Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommendations regarding the importance of reading and talking to infants. Recommendations and benefits of reading with infants are listed on the back cover as well.

Infant Reading Education

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant mothers
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
• maternal age at least 16 years old,
• comfort speaking English during their visit and reviewing/comprehending study materials without a translator.

You may not qualify if:

• Non-meeting the above.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

• Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.

  PMID: 28450082 BACKGROUND

• Hutton JS, Lin L, Gruber R, Berndsen J, DeWitt T, Van Ginkel JB, Ammerman RT. Shared Reading and Television Across the Perinatal Period in Low-SES Households. Clin Pediatr (Phila). 2018 Jul;57(8):904-912. doi: 10.1177/0009922817737077. Epub 2017 Oct 25.

  PMID: 29067842 BACKGROUND

• Hutton JS, Huang G, Crosh C, DeWitt T, Ittenbach RF. Shared reading with infants: SharePR a novel measure of shared reading quality. Pediatr Res. 2023 Mar;93(4):976-984. doi: 10.1038/s41390-022-02178-6. Epub 2022 Jul 19.

  PMID: 35854086 DERIVED

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Mothers will be blinded as to the specific aims of the study other than that it involves "safe sleep and reading with your baby."
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: July 24, 2019
• Study Start: February 25, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)